JPRN-UMIN000009318
Completed
Phase 2
A Phase II trial of irinotecan / S-1 (IRIS) + alfa (Panitumumab/Bevacizumab) as 2nd line chemotherapy for metastatic colorectal cancer (mCRC) A multicenter phase II trial of TS1 + Irinotecan (IRIS) + Bevacizumab as second line treatment in patients with KRAS mutant type unresectable advanced colorectal cancer (mCRC). - IRIS-PB trial -Part B
Yamaguchi University Department of Digestive Surgery and Surgical Oncology0 sites30 target enrollmentNovember 12, 2012
Conditionsmetastatic colorectal cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- metastatic colorectal cancer
- Sponsor
- Yamaguchi University Department of Digestive Surgery and Surgical Oncology
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\)Presence of active multiple primaries. Active multiple primaries is simultaneous or metachronous with disease\-free interval of 5 years or more. But, carcinoma in situ and skin cancer which are judged to be recovery by medical treatment are excluded. 2\)Massive pleural effusion or ascites that required drainage 3\)Symptomatic brain meta 4\)Severe psychiatric disease or psychiatric symptoms 5\)Severe complications 6\)Undertook radiation therapy for abdominal lesions 7\)History of serious drug hypersensitivity or a history of drug allergy 8\)Pregnant or lactating woman 9\)Requiring steroid drug 10\)Receiving flucytosine, atazanavir sulfate 11\)Uncontrollable diarrhea 12\)Uncontrollable peptic ulcer 13\)High\-grade peritoneal metastasis and stricture 14\)History of the perforation of the digestive tract within 6 months before registration 15\)History of the thromboembolism, brain infarction, lung infarction, brain infarction or pneumonitis 16\)Operation within 28 days 17\)Congenital bleeding predisponency or abnormality of hemostasis 18\)Patients have anticoagulant agent 19\)Not appropriate for the study at the physician's assessment
Outcomes
Primary Outcomes
Not specified
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